12 October 2017
“New cancer medicines should always be better than those they aim to replace,” says Eveline Scheres, Chair of the ECL Access to Medicines Task Force.
“As there is significant pressure on healthcare budgets across Europe, it is imperative that we invest in treatments that offer the most benefit for patients.” Her remarks follow a recent publication of the British Medical Journal (BMJ), which analysed the efficacy of 48 new treatments approved for 68 indications by the European Medicines Agency (EMA) between 2009-2013, finding ‘marginal improvements’ in the overall survival (OS) and the quality of life.
Key findings from the BMJ
The BMJ study shows that only 35% (24 indications) resulted in prolonged survival ranging from 1 to 5.8 months (2.7 median). Moreover, out of the treatments associated with the prolonged survival, only 48% (11 indications) were deemed to be clinically meaningful according to ESMO standards. Only 10% (7 indications) showed improvement in the quality of life at the time of market approval. Hence, only 51% of indications (35) were associated with improved survival or quality of life. Most approvals were based on improvements in surrogate endpoints (mostly progression free survival).
Pressure on healthcare systems
The EMA approval is usually (and should be) perceived as a guarantee of efficacy, yet in only one out of three cases the approval was based on documented survival benefits. This gives little reason to be optimistic. Given the expanding impact innovative medicines have on national healthcare budgets, there is little room for ‘marginal improvements’ set against a high cost. As European countries struggle with the sustainability of their healthcare systems, this study raises the question: are new medicines expensive because they are effective or simply because they are new? According to Eveline Scheres, “new medicines should always add value to the existing ones, especially if they are priced with an innovation tag. Regardless, they should be introduced to the market at a fair price.” Moreover, the EMA should initiate more post-authorisation efficacy studies, in order to be sure that the new medicines deliver meaningful value to patients and do not cause any unnecessary harm.
Teaming up
Established in 2016, the ECL Access to Medicines Task Force aims to make cancer medicines available for all cancer patients in Europe by insisting on accessibility, sustainability of the health care system and transparency of drug prices. The Task Force strongly believes in the power of dialogue. We urge all stakeholders to push for innovative improved treatments, improving both survival and the quality of life of cancer patients, instead of investments in me-too products. Currently, 25 national/regional cancer leagues, representing over 450 million Europeans, have signed the Task Force’s Declaration of Intent.
